In January of 2009, two Georgia residents filed suit against the manufacturers of the Kugel hernia patch. Like many other Americans, these Georgians allege that they have been injured by defective hernia patches.
8. The Kugel Mesh line of products was first manufactured by Surgical Sense, Inc. in or around 1996. Bard acquired the Kugel Mesh line of hernia repair products in January 2000. In 2001 Bard introduced the Composix Kugel Mesh Patch through its subsidiary, Davol. The 510k application was submitted to the Federal Drug Administration (“FDA”) on January 22, 2001. Following the 510k application the Kugel Mesh was authorized by the FDA as a Class II medical device.
9. Dr. Robert D. Kugel invented the Composix Kugel Mesh Patch, a polypropylene mesh prosthetic device developed to repair abdominal or ventral hernias. The design employs a “memory coil ring” or “PET“ coil ring which deploys once inserted. The ring is a hard solid material that surrounds the mesh. The device is inserted behind the muscular defect in the abdomen. The ring deploys and opens after insertion. This mechanism was to allow for a smaller incision. Davol represented the Kugel Mesh Patch to be an appropriate, cost-effective and suitable product for implantation.
10. Defects in the design and manufacturing in certain Bard Composix Kugel Mesh Patches are demonstrated by the memory recoil ring (“ring”) when deployed and open the patch after insertion may break under the stress of placement in the intra-abdominal space. Once this ring, that is a solid hard material, breaks it can cause serious injury such as intestinal perforations, migration of the broken ring through the abdominal wall in to the pelvis; intestinal fistulas (abnormal passageways between the intestine and other organs); abscess; sepsis and death.
11. When the FDA believes a medical product is dangerous or defective and predictably could cause serious health problems or death the product may be removed from the market or recalled by the FDA. The FDA issued a Class I recall, the highest level of recall available, of the Bard Composix Kugel Mesh Extra-Large Oval Patch, Large Oval Patch and Large Circle Patch.
12. On January 13, 2006, Davol and Bard announced the recall of the Kugel Mesh Extra-Large Patch. In March 2006 the Defendants also announced the recall of the Large Patch as well. Subsequent recalls by the Defendants also were announced.
COMES NOW, the Plaintiffs, W. Frank Cofer and Camille Cofer, by and through their attorney of record, for causes of action against Defendants; Davol, Inc. and CR. Bard, Inc., and states for their Complaint as follows:
I. PARTIES
1. Plaintiff, W. Frank Cofer, is a resident of Gwinnett County, Georgia.
2. Plaintiff, Camille Cofer, is the spouse of W. Frank Cofer and resides with Plaintiff, W. Frank Cofer, in Gwinnett County, Georgia.
3. Defendant, Davol, Inc., (“defendant” or “Davol”) is a foreign corporation incorporated under the laws of the State of Delaware. The principal place of business for Davol is located at 100 Sockanosset Crossroads, P.O. Box 8500, Cranston, Rhode Island 02920. Davol transacts business in the State of Georgia as well as throughout the United States. Its business is primarily for the design, manufacture, labeling, testing, distribution, advertising, marketing, promotion and sale of healthcare products and supplies to distributors, physicians, hospitals and all other providers and facilities. The registered agent for Davol is The Corporation Trust Company located at Corporation Trust Center, 1209 Orange Street, Wilmington, Delaware 19801.
4. Defendant, C. R. Bard, Inc., aka, C. R. Bard, Inc., and C. R. Bard, Incorporated (“defendant” or “Bard”) is both a domestic for profit corporation and a foreign corporation incorporated under the laws of the State of New Jersey with its principal office and place of business at 730 Central Avenue, New Providence, New Jersey 07974. Bard is the corporate parent/stockholder of Davol. Bard is a corporation doing business in the State of Georgia that designs, manufactures, labels, tests, distributes, advertises, markets, promotes and sells medical products and supplies to distributors, physicians, hospitals and any and all other providers and facilities throughout the United States and the State of Georgia. The registered agent for Bard is Stephen J. Long, 730 Central Avenue, Murray Hill, NJ 07974.
II. JURISDICTION AND VENUE
5. The Defendants are subject to jurisdiction in this Court as they transact business in the State of Georgia, as they have committed tortious acts or omissions in the State of Georgia, and have committed tortious injury in this State by acts or omissions outside the State.
III. FACTS
6. This action involves the Bard Composix Kugel Mesh Patch (“Kugel Patch”), a medical device manufactured by the Defendants. The Kugel Patch was sold by the Defendants as an implant for use in hernia repair surgery.
7. A hernia occurs when a muscle is too weak to hold the contents behind the muscle in place and as such a rupture may occur which causes the contents to push onto the muscle and the entire area to protrude. The Kugel Patch was designed and sold to treat abdominal or ventral hernias.
8. The Kugel Mesh line of products was first manufactured by Surgical Sense, Inc. in or around 1996. Bard acquired the Kugel Mesh line of hernia repair products in January 2000. In 2001 Bard introduced the Composix Kugel Mesh Patch through its subsidiary, Davol. The 510k application was submitted to the Federal Drug Administration (“FDA”) on January 22, 2001. Following the 510k application the Kugel Mesh was authorized by the FDA as a Class II medical device.
9. Dr. Robert D. Kugel invented the Composix Kugel Mesh Patch, a polypropylene mesh prosthetic device developed to repair abdominal or ventral hernias. The design employs a “memory coil ring” or “PET“ coil ring which deploys once inserted. The ring is a hard solid material that surrounds the mesh. The device is inserted behind the muscular defect in the abdomen. The ring deploys and opens after insertion. This mechanism was to allow for a smaller incision. Davol represented the Kugel Mesh Patch to be an appropriate, cost-effective and suitable product for implantation.
10. Defects in the design and manufacturing in certain Bard Composix Kugel Mesh Patches are demonstrated by the memory recoil ring (“ring”) when deployed and open the patch after insertion may break under the stress of placement in the intra-abdominal space. Once this ring, that is a solid hard material, breaks it can cause serious injury such as intestinal perforations, migration of the broken ring through the abdominal wall in to the pelvis; intestinal fistulas (abnormal passageways between the intestine and other organs); abscess; sepsis and death.
11. When the FDA believes a medical product is dangerous or defective and predictably could cause serious health problems or death the product may be removed from the market or recalled by the FDA. The FDA issued a Class I recall, the highest level of recall available, of the Bard Composix Kugel Mesh Extra-Large Oval Patch, Large Oval Patch and Large Circle Patch.
12. On January 13, 2006, Davol and Bard announced the recall of the Kugel Mesh Extra-Large Patch. In March 2006 the Defendants also announced the recall of the Large Patch as well. Subsequent recalls by the Defendants also were announced.
13. At all times herein the Defendants knew, or in the exercise of reasonable care should have known that the aforesaid products were not properly manufactured, tested, inspected, packaged, labeled, distributed, marketed, examined, sold, supplied, prepared and/or provided with proper warnings, were not suitable for the purpose they were intended and were unreasonably likely to injure the products' users.
14. Defendants did not timely apprise the public and medical providers who were users of the defective product, despite Defendants' knowledge that the rings failed and serious injuries occurred.
15. Defendants' conduct, as described in the proceeding paragraphs amounts to conduct purposely committed, which Defendants knew was dangerous, needless and reckless, without regard to consequences or the rights and safety of the Plaintiffs.
16. The Bard Composix Kugel Mesh Patches present an unreasonable risk of danger and injury in the following respects:
a. the memory recoil of the Bard Composix Kugel Mesh Extra Large Patch and Large Patches are likely to malfunction after being implanted.
b. the Bard Composix Kugel Mesh Extra Large and Large Patches were defectively designed;
c. the Bard Composix Kugel Mesh Extra Large and Large Patches did not as sold meet the expectation of the ordinary medical provider or consumer in that the device may result in injury rather that the use as promoted.
d. the Bard Composix Kugel Mesh Extra Large and Large Patches were inadequate or insufficient to maintain its integrity during normal use after implantation in the consumer/patient; and
e. such further and additional defects as discovery and evidence reveal.
17. Plaintiff W. Frank Cofer became symptomatic for pain and discomfort in the abdomen and underwent a hernia repair and Defendants' defective patch was used.
18. As a result of the defective product, Plaintiff W. Frank Cofer, has undergone multiple surgeries and suffered extensive complications arising from the insertion of the defective products listed above.
19. As a direct and proximate cause of Defendants' conduct and the recalled Bard Composix Kugel Mesh Patches, Plaintiff W. Frank Cofer suffered severe injury that is continuing in nature and requires medical monitoring and care.
IV. COUNT 1 NEGLIGENCE
20. Plaintiffs incorporate by reference all preceding paragraphs as if fully set forth herein and further allege as follows:
21. Defendants at all times relevant herein, had a duty to exercise reasonable care in the design, manufacture, labeling, testing, distributing, advertising, marketing, promoting, warning and/or sale of the Kugel Mesh Patch into the stream of commerce, including a duty to ensure that the Kugel Mesh Patches did not cause users to suffer from reasonably foreseeable, dangerous side effects and serious health problems.
22. Defendants failed to exercise ordinary care in the design, manufacture, labeling, testing, distributing, advertising, marketing, promoting, warning and/or sale of Kugel Mesh Patches into the interstate commerce, and Defendants knew or should have known that Kugel Mesh Patches created a high risk of unreasonable and foreseeable dangerous side effects, including death.
23. Defendants breached their duty to Plaintiffs as follows:
a. In the designing, manufacturing, labeling, testing, distributing, advertising, marketing, promoting, warning and/or sale of Kugel Mesh Patches such that there was a failure to use ordinary care to avoid causing substantial harm to individuals receiving implants of the Kugel Mesh Patches;
b. By failing to follow U.S. Food & Drug Administration manufacturing practices that resulted in Defendants' failure to properly investigate adverse effects of implanted Kugel Mesh Patches and failing to document reports of the adverse effects.
c. By failing to exercise acceptable and adequate quality control procedures resulting in inaccurate and inadequate testing to determine whether the patch was safe and effective;
d. By failing in the duty to disclose or warn that adequate testing had not been performed which would have demonstrated that the use of the Kugel Mesh Patches posed serious potential harm and Defendants failed to warn of the harm and the severity of said harm and associated medical conditions caused by the Kugel Mesh Patch;
e. By failing to use qualified professionals and staff in the design, manufacture, labeling, testing, distributing, advertising, marketing, promoting, warning and/or sale of the Patch;
f. By failing to report the accurate results of testing for safety and efficacy performed on Kugel Mesh Patches and failing to report said results to prevent harm to other consumers by refusing to withdraw Kugel mesh patches from the U.S. Market based on reports concerning and relating to adverse events in patients where the above referenced Kugel Mesh Patches were implanted.
g. By failing in a duty to make sure the Kugel Patch would maintain its proper function without damage once implanted in the consumer as expected to implantation.
24. Defendants knew or should have known that bodily injury was likely to occur as a result of the defective and unreasonably dangerous design and manufacture of the Kugel Mesh Patch products as identified above.
25. Plaintiffs as a result of the defective and unreasonably dangerous Patches have sustained and will continue to sustain damages in the future as follows:
a. Medical expenses in the past and future;
b. Permanent physical injury to his body as a whole including disfiguration;
c. Loss of income and/or diminution of the ability to earn income in the future;
d. Loss of enjoyment of life and/or loss of companionship and consortium;
e. Physical pain and mental and emotional pain and suffering as well as anxiety in the past and future.
26. Punitive damages should be awarded based on the egregious conduct of the Defendants who continued to market, promote, sell and distribute the Kugel Mesh Patches as identified with actual knowledge that the surgical product for repair of hernias was failing in its intended use and showed deliberate indifference and conscious disregard for the public who trusted the Defendants to provide a safe product. Defendants have a history of showing deliberate indifference and disregard for the public and punitive damages should be awarded.
COUNT 2 STRICT LIABILITY PURSUANT TO O.C.G.A. § 51-1-11
27. Plaintiffs incorporate by references all preceding paragraphs as if fully set forth herein and further allege as follows:
28. Defendants DAVOL and BARD engaged in the business of designing, manufacturing, labeling, testing, distributing, advertising, marketing, promoting, and selling Kugel Mesh Patches to medical providers and practitioners in the State of Georgia as well as the entire United States. They have knowingly and intentionally placed the device into the stream of commerce with full knowledge that said device would be used in the surgical repair of hernias.
29. Defendants intended for the Kugel Mesh Patches to be surgically implanted into members of the general public, including the Plaintiff W. Frank Cofer, and knew or should have known that the product would be surgically implanted into members of the general public, including Plaintiff, W. Frank Cofer.
30. Implantation of the Kugel Mesh Patch was reasonably foreseeable into Plaintiff W. Frank Cofer and was used for the purpose as it was intended by the Defendants.
31. Defendants were situated in the chain of commerce and designed, manufactured, tested, labeled, marketed, packaged, advertised, distributed and sold Kugel Mesh Patches in the course of its regular business.
32. Kugel Mesh Patches were used by Plaintiff W. Frank Cofer in a manner reasonably anticipated and foreseeable and in the manner for which it was intended;
33. Kugel Mesh patches were in the same or substantially the same, defective and unreasonably dangerous condition when put to their reasonably anticipated and foreseeable use;
34. Kugel Mesh Patches lacked adequate warnings of its defective and unreasonably dangerous condition;
35. The devices identified above were defective and unsafe in the design, manufacture and were defective at the time of distribution and implantation into Plaintiff W. Frank Cofer. The products were defective in that they were improperly designed, improperly manufactured and proper warnings did not accompany said devices indicating serious injury could occur wot the user when used in their intended and foreseeable manner to wit:
a. The memory recoil ring of the Kugel Mesh Patch was likely to malfunction when implanted;
b. The Kugel Mesh Patch was not properly manufactured;
c. The Kugel Mesh Patch was defectively designed;
d. The Kugel Mesh Patch was not safe as the ordinary user would expect;
e. Defendants failed to warn of the above defects;
f. There may be additional defects as discovery and evidence reveal.
36. Defendants knew that the product or device would be used by the user without inspection for defects.
37. With respect to Plaintiff W. Frank Cofer, the product was used for its intended purpose.
38. Warnings of the danger that were known or reasonably scientifically known at the time of the distribution of the product were not provided by the Defendants. The ordinary use of the product would not have known of the substantial danger involved with reasonably foreseeable use of the product. Defendants failed to warn of the known or knowable likelihood of injury arising from the danger and risks with the use of* product.
39. Plaintiff Cofer did not know, nor did Plaintiff have reason to know, at the time of the use of this product the existence of the defects. Theses defects caused the Plaintiff the injuries described herein and the injuries from which the Plaintiffs continue to suffer.
40. Plaintiffs as a result of the defective and unreasonably dangerous Patch have sustained and will continue to sustain damages in the future as follows:
a. Medical expenses in the past and future;
b. Permanent physical injury to his body as a whole including disfiguration;
c. Loss of his income and/or diminution of the ability to earn income in the future;
d. Loss of enjoyment of life and/or loss of companionship and consortium;
e. Physical pain and mental and emotional pain and suffering as well as anxiety in the past and future.
41. Defendants' conduct in continuing to market, sell and distribute Kugel Mesh Patches after obtaining knowledge that the product was failing and not performing as represented and intended, showed deliberate indifference to and conscious disregard for the safety of the users of the product justifying an award of additional damages for aggravating circumstances in such a sum which will serve to deter DAVOL, BARD and others from similar conduct in the future.
OUNT 3 STRICT LIABILITY FAILURE TO WARN
42. Plaintiffs incorporate by reference all preceding paragraphs as if fully set forth herein and further allege as follows:
43. Defendants DAVOL and BARD engaged in the business of designing, manufacturing, labeling, testing, distributing, advertising, marketing, promoting, and selling of Kugel Mesh Patches to medical providers and practitioners in the State of Georgia as well as the entire United States, They have knowingly and intentionally placed the device into the stream of commerce with full knowledge that said device would be used in the surgical repair of hernias;
44. Defendants intended for the Kugel Mesh Patches to be surgically implanted into members of the general public, including the Plaintiff W. Frank Cofer, and knew or should have known that the product would be surgically implanted into members of the general public, including Plaintiff, W. Frank Cofer.
45. Placement of the Kugel Mesh Patch into Plaintiff W. Frank Cofer was reasonably foreseeable and was used in the manner for which it was intended by all Defendants.
46. Defendants were situated in the chain of commerce and designed, manufactured, tested, labeled, marketed, packaged, advertised, distributed and sold Kugel Mesh Patches in the course of its regular business.
47. Kugel Mesh Patches were used by Plaintiff W. Frank Cofer in a manner reasonably anticipated and foreseeable and in the manner for which it was intended;
48. Kugel Mesh patches were in the same or substantially the same, defective and unreasonably dangerous condition when put to their reasonably anticipated and foreseeable use;
49. Kugel Mesh Patches lacked adequate warnings of its defective and unreasonably dangerous condition:
a. The memory recoil ring of the Kugel Mesh Patch was likely to malfunction when implanted;
b. The Kugel Mesh Patch was not properly manufactured;
c. The Kugel Mesh Patch was defectively designed;
d. The Kugel Mesh Patch was not safe as the ordinary user would expect;
e. Defendants failed to warn of the above defects;
f. There ma be additional defects as discover and evidence reveal.
50. Defendants did not give adequate warnings of the dangerous conditions that could arise with the intended use of the product or the defective nature of the Patches indentified herein above when it knew or should have known of its dangerous and defective nature.
51. Warnings of the danger that were known or reasonably scientifically known at the time of the distribution of the product were not provided by the Defendants. The ordinary user of the product would not have known of the substantial danger involved with reasonably foreseeable use of the product. Defendants failed to warn of the known or knowable likelihood of injury arising from the danger and risks with the use of the product.
52. Plaintiff W. Frank Cofer used the product for its intended purpose and the product was in the same condition as when distributed and sold by the Defendants.
53. Plaintiff Cofer did not know, nor did Plaintiff have reason to know, at the time of the use of this product the existence of the defects. Theses defects caused the Plaintiff the injuries described herein and the injuries from which the Plaintiffs continue to suffer.
54. Plaintiffs as a result of the defective and unreasonably dangerous Patch have sustained and will continue to sustain damages in the future as follows:
a. Medical expenses in the past and future;
b. Permanent physical injury to his body as a whole including disfiguration;
c. Loss of his income and/or diminution of the ability to earn income in the future;
d. Loss of enjoyment of life and/or loss of companionship and consortium;
e. Physical pain and mental and emotional pain and suffering as well as anxiety in the past and future.
55. Defendants' conduct in continuing to market, sell and distribute Kugel Mesh Patches after obtaining knowledge that the product was failing and not performing as represented and intended, showed deliberate indifference to and conscious disregard for the safety of the users of the product justifying an award of additional damages for aggravating circumstances in such a sum which will serve to deter DAVOL, BARD and others from similar conduct in the future.
COUNT 4 BREACH OF EXPRESS WARRANTY OF MERCHANTABILITY/MISREPRESENTATION
56. Plaintiffs incorporate by reference all preceding paragraphs as if fully set forth herein and further allege as follows:
57. Manufacturing, design, labeling, testing, distributing, advertising, marketing, promoting and selling of the Kugel Mesh Patch were expressly warranted to be safe for use by the Plaintiff W. Frank Cofer and other members of the public.
58. Defendants had knowledge at the time the express warranties were made that the products to be used were in all respects fit, safe, effective and proper for the purpose intended. There were no warnings that the product had dangerous propensities that were known or should have been known by the Defendants at the time of distribution.
59. Plaintiffs relied upon the skill and judgment of the Defendants based on the express warranty when the product was used. The warranties and representations made by the Defendants were untrue in severe injuries to the Plaintiffs and therefore the product was unsuited for the purpose intended.
60. Plaintiffs as a result of the defective and unreasonably dangerous Patch, warranted by the Defendants, will have sustained and will continue to sustain damages in the future as follows:
a. Medical expenses in the past and future;
b. Permanent physical injury to his body as a whole including disfiguration;
c. Loss of his income and/or diminution of the ability to earn income in the future;
d. Loss of enjoyment of life and/or loss of companionship and consortium;
e. Physical pain and mental and emotional pain and suffering as well as anxiety in the past and future.
61. Defendants' conduct in continuing to market, sell and distribute Kugel Mesh Patches after obtaining knowledge that the product was failing and not performing as represented and intended, showed deliberate indifference to and conscious disregard for the safety of the users of the product justifying an award of additional damages for aggravating circumstances in such a sum which will serve to deter DAVOL, BARD and others from similar conduct in the future.
COUNT 5 BREACH OF IMPLIED WARRANTY
62. Plaintiffs incorporate by references all preceding paragraphs as if fully set forth herein and further allege as follows:
63. Defendants designed, manufactured, tested, labeled, packaged, distributed and old Kugel Mesh Patches used in the surgical repair of hernia and implanted into Plaintiff W. Frank Cofer's abdomen. Prior to the implantation the Defendants impliedly warranted to Plaintiffs and to the health care providers, that the products were of merchantable quality and for the use in which they were intended.
64. At the time of the sale of the Kugel Mesh Patches the Defendants knew that they were intended to be used for the surgical repair of hernias and would be implanted into the body for the repair of hernias.
65. Plaintiff and health care providers reasonably relied on Defendants' judgment, statements and indications that the Kugel Mesh Patches identified herein above were fit for the intended purpose.
66. When Defendants distributed the Kugel Mesh Patch they were distributed and sold by the Defendants who knew or should have known that the Patch identified herein above was unsafe for the intended purpose, not of merchantable quality as warranted by the Defendants, were dangerous when used for their intended purpose and when implanted in the consumer of the produce would cause serious injury to the user.
67. Plaintiffs as a direct and proximate result of the defective and unreasonably dangerous Patch, warranted by the Defendants, will have sustained and will continue to sustain damages in the future as follows:
a. Medical expenses in the past and future;
b. Permanent physical injury to his body as a whole including disfiguration;
c. Loss of his income and/or diminution of the ability to earn income in the future;
d. Loss of enjoyment of life and/or loss of companionship and consortium;
e. Physical pain and mental and emotional pain and suffering as well as anxiety in the past and future.
68. Defendants' conduct in continuing to market, sell and distribute Kugel Mesh Patch after obtaining knowledge that the product was failing and not performing as represented and intended, showed deliberate indifference to and conscious disregard for the safety of the users of the product justifying an award of additional damages for the aggravating circumstances in such a sum which will serve to deter DAVOL, BARD and others from similar conduct in the future.
COUNT 6 VIOLATION OF GEORGIA'S FAIR BUSINESS PRACTICE ACT PURSUANT TO O.C.G.A. § 10-1-399
69. Plaintiffs incorporate by reference all preceding paragraphs as if fully set forth herein and further allege as follows:
70. Defendants were situated in the chain of commerce and designed, manufactured tested, labeled, marketed, packaged, advertised, distributed and sold Kugel Mesh Patches in the course of it regular business.
71. Defendants DAVOL and BARD engaged in the business of designing, manufacturing, labeling, testing, distributing, advertising, marketing, promoting, and selling of Kugel Mesh Patches to medical providers and practitioners in the State of Georgia as well as the entire United States. They have knowingly and intentionally placed the device into the stream of commerce with full knowledge that said device would be used in the surgical repair of hernias;
72. At the time of the sale of the Kugel Mesh Patches the Defendants knew that they were intended to be used for the surgical repair of hernias and would be implanted into the body for the repair of hernias.
73. Plaintiff and health care providers reasonably relied on Defendants' judgment, statements and indications that the Kugel Mesh Patches identified herein above were fit for the intended purpose.
74. When Defendants distributed the Kugel Mesh Patch they were distributed and sold by the Defendants who knew or should have known that the Patch identified herein above was unsafe for the intended purpose, not of merchantable quality as warranted by the Defendants, were dangerous when used for their intended purpose and when implanted in the consumer of the produce would cause serious injury to the user.
75. Plaintiffs as a direct and proximate result of the defective and unreasonably dangerous Patch, warranted by the Defendants, will have sustained and will continue to sustain damages in the future as follows:
a. Medical expenses in the past and future;
b. Permanent physical injury to his body as a whole including disfiguration;
c. Loss of his income and/or diminution of the ability to earn income in the future;
d. Loss of enjoyment of life and/or loss of companionship and consortium;
e. Physical pain and mental and emotional pain and suffering as well as anxiety in the past and future.
76. Defendants' conduct in continuing to market, sell and distribute Kugel Mesh Patch after obtaining knowledge that the product was failing and not performing as represented and intended, showed deliberate indifference to and conscious disregard for the safety of the users of the product justifying an award of additional damages for the aggravating circumstances in such a sum which will serve to deter DAVOL, BARD and others from similar conduct in the future.
COUNT 7 LOSS OF CONSORTIUM
77. Plaintiffs incorporate by reference all preceding paragraphs as if fully set forth herein and further allege as follows:
78. Plaintiff Camille Cofer is the long-time spouse of Plaintiff W. Frank Cofer.
79. Plaintiff Camille Cofer over the course of their marriage has relied on Plaintiff W. Frank Cofer to provide companionship and care for their child.
80. Defendants DAVOL and BARD engaged in the business of designing, manufacturing, labeling, testing, distributing, advertising, marketing, promoting, and selling of Kugel Mesh Patches to medical providers and practitioners in the State of Georgia as well as the entire United States. They have knowingly and intentionally placed the device into the stream of commerce with full knowledge that said device would be used in the surgical repair of hernias;
81. Two Kugel Mesh Patches were implanted into Plaintiff W. Frank Cofer to surgically repair his abdominal hernia.
82. At the time of the sale of the Kugel Mesh Patches the Defendants knew that they were intended to be used for the surgical repair of hernias and would be implanted into the body for the repair of hernias.
83. Plaintiff and health care providers reasonably relied on Defendants' judgment, statements and indications that the Kugel Mesh Patches identified herein above were fit for the intended purpose.
84. When Defendants distributed the Kugel Mesh Patch they were distributed and sold by the Defendants who knew or should have known that the Patch identified herein above was unsafe for the intended purpose, not of merchantable quality as warranted by the Defendants, were dangerous when used for their intended purpose and when implanted in the consumer of the produce would cause serious injury to the user.
85, Plaintiff W. Frank Cofer had defective Kugel Mesh Patches implanted surgically in his body to repair and abdominal hernia which resulted in serious injury and the wound as a result of the injury still over an almost two year period has not healed.
86. Plaintiff Camille Cofer as a direct and proximate result of the defective and unreasonably dangerous patch, warranted by the Defendants, has sustained and will continue to sustain damages in the future as follows:
a. Loss of enjoyment of life and/or loss of companionship and consortium;
b. Emotional pain and suffering as well as anxiety in the past and future.
WHEREFORE, having fully stated their Complaint, the Plaintiffs pray that:
1) summons and process issue and the Defendants be served as provided by law;
2) the Plaintiffs have a jury trial;
3) the Plaintiffs be awarded compensatory damages in an amount decided by an enlightened jury;
4) the Plaintiffs be awarded punitive damages under O.C.G.A. § 51-12-5.1 in an amount decided by an enlightened jury;
5) judgment be entered in favor of the Plaintiffs and against the Defendants;
6) all costs be cast upon the Defendants; and
7) the Court grant to the Plaintiffs such other and further relief as the Court deems just and proper.
Respectfully submitted this 6th day of January, 2009.
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